To go at the OECD level, a project should be of interest to the majority (if not all) of the Member countries
All OECD Member countries agree on accepting a project at the OECD level
OECD can provide support in coordinating activities, e.g. organising meetings, ensuring expert input from Member countries
OECD coordinates commenting rounds
OECD makes TGs/GDs publicly available on their website
The Organisation for Economic Co-operation and Development (OECD) is an international organisation that works with governments, policymakers and citizens, to establish evidence-based international standards and find solutions to a range of social, economic and environmental challenges.
OECD consists of 38 Member countries, 6 OECD Accession Candidates and 5 Key Partners. Chemical Safety and Biosafety is one of more than 25 topics the OECD is dedicated to. The OECD work on this topic is carried out under the Environment, Health and Safety Programme which is overseen by the Chemicals and Biotechnology Committee (CBC). For the topic of Chemical Safety and Biosafety the OECD Mutual Acceptance of Data (MAD) is an important cornerstone which is built upon a foundation of test guidelines and good laboratory practice. If a study has been conducted according to OECD Test Guidelines and OECD Principles of Good Laboratory Practice (GLP) approaches, in a test facility compliant with a national GLP monitoring programme validated by OECD, then all OECD member countries as well as countries adherents to MAD (To date; Non-OECD member countries full adherents to MAD are: Argentina, Brazil, India, Malaysia, Singapore, South Africa and Thailand).
The OECD Test Guidelines (TGs) are a collection of internationally agreed testing methods to assess the effects of chemicals on the environment and human health. They are used by governments, industry and independent laboratories to assess the safety of chemicals, primarily in a regulatory context. Further information and guidance on TGs are published in the OECD Series on Testing and Assessment, e.g. validation reports, guidance documents or detailed review papers supporting the use of OECD TGs but do not fall under MAD.For further details please consult the NanoHarmony Training Material - From science to standards and harmonised OECD Test Guidelines.
OECD provides a unique forum and knowledge hub for data and analysis, exchange of experiences, best-practice sharing, and advice on public policies and international standard-setting. The OECD Test Guidelines (TGs) for the testing of chemicals are a collection of the most relevant internationally agreed testing methods used by governments, industry and independent laboratories to assess the safety of chemicals. They are primarily used in regulatory safety assessment and subsequent chemical notification and registration. The set of OECD TGs is updated to keep pace with progress in science and countries’ regulatory needs. OECD-wide networks of National Coordinators and experts provide input from scientists in government, academia, and industry (From OECD website: www.oecd.org). Industry participation in the Chemicals and Biotechnology Committee (CBC) activities is organised by the Business and Industry Advisory Committee to the OECD (BIAC), while trade union representation is organised by the Trade Union Advisory Committee to the OECD (TUAC). The participation of environmental NGOs across the OECD is coordinated by the European Environmental Bureau (EEB). The International Council for Animal Protection in OECD Programmes (ICAPO) participates as an invited experts in meetings where issues relating to animal welfare are discussed. These stakeholders can provide direct expertise and inputs to activities of the OECD Test Guidelines Programme (TGP).
Funding is in the power of OECD Member countries.
National Coordinator may support an OECD project ideation, by notably screening national regulatory needs
Working Party of National Coordinators of the OECD Test Guidelines Programme (WNT) discusses and comments on project proposals to be part of the OECD TGs Programme
WNT provides a sharing/ discussion platform and ensures regulatory needs are addressed in the development of the OECD TGs/GDs
Circulates calls for inter-laboratory and for commenting comparison in the national networks with the support of the OECD secretariat
WNT provides comments on draft document(s) and approves final OECD documents.
WNT monitors the status of the TGs/GDs and decides on the need for update or deletion of TGs/GDs
Each OECD Member country and countries adhering to Mutual Acceptance of Data (MAD) have one or two representative(s) named National Coordinators (NCs). Member Countries have their own criteria and decisions on who will become their National Coordinator. Together, they form the Working Party of National Coordinators of the TGP(WNT).
All activities related to the OECD TGP, including proposals for Test Guidelines (TGs) and the development or updating of other documents, are normally discussed at the WNT meeting. The WNT meeting is chaired by one of the National Coordinators, who is elected for a period of three years in line with the timeline of the work plan of the Test Guidelines Programme (i.e. the three-year rolling work plan for the Programme, with annual updates (OECD GD 1, as revised in 2009)). Vice-Chairs are also elected for that three-year period. The purpose of the WNT meeting is to reach a consensus on the programme of work and on draft TG and related documents, to be proposed to the parental WNT’s body; the Chemicals and Biotechnology Committee. Occasionally, when it is appropriate to avoid unnecessary delay, agreement on a proposal for Test Guideline or other Test Guideline-related document development may also be reached by written procedure (OECD GD1. Guidance Document for the Development of OECD Guidelines for the Testing of Chemicals (as revised in 2009)).
The Working Group of National Coordinators of the TGs programme (WNT) oversees the development of Test Guidelines (TGs), Guidance Documents (GDs) and other OECD documents in the TGs programme (See the different documents in the NanoHarmony Training Material - From science to standards and harmonised OECD Test Guidelines). The WNT makes decisions on TGs (approves and updates TGs) and decides on project proposals to be included in the work plan of the OECD Test Guidelines Programme (TGP). The WNT meets annually at the OECD, usually in April. National Coordinators nominate experts, scientists from research and regulatory areas to work together on developing methods and guidance. In addition, the Business and Industry Advisory Committee (BIAC), the European Environmental Bureau which coordinates the voice of environmental non-governmental organisations within the OECD Environment Policy Committee (EPOC), and the International Council on Animal Protection (ICAPO) can provide expertise and inputs. Broad participation in work on TGs development helps to ensure sound science and international regulatory acceptance of test methods (See Pre-OECD phase). Member countries see the new input and, later, output in the form of newly proposed projects to the WNT and get to comment and approve TG/GD documents to become OECD TGs/GDs.
Extracted from the NanoHarmony Training - From science to standards and harmonised OECD Test Guidelines
‘The OECD and its relevant committees’.
National Coordinators (NCs) of the WNT are thus the key contact point for various stakeholders participating in the OECD TGP. They can be contacted at any time by institutions interested in leading a project or stakeholders such as contract research organisations, willing to participate in a particular project. NCs will advise the next steps depending on the request (e.g. look for financial support for a potential project). Also together with other national delegates being part of the working party (e.g. from the Working Party on Manufactured Nanomaterials), NCs may circulate calls for interlaboratory comparison and commenting in their national network (See Development at OECD) and consult and compile comments received from national experts and scientific societies on draft TGs/GDs in national position paper (See Commenting and approval at OECD).
Funding is in the power of OECD Member countries. Some Member countries are not as involved as others in TG development due to budget limitations. It is also up to the Member countries to set the criteria for the selection of members of their national delegation and the responsible institutions. Each Member country does it in different ways, depending on how big the country is and/or how many experts are available. For example, sometimes only one delegate represents its country at various OECD committees and working groups/parties.
OECD Secretariat facilitates the discussion amongst OECD Member countries and potentially involves other OECD bodies or relevant stakeholders
OECD Secretariat facilitates any necessary discussions
Can support the establishment of the (Ad Hoc) expert Groups
OECD Secretariat facilitates the discussions (by organising meetings in collaboration with the lead country)
Facilitate the recruitment of participants for interlaboratory comparisons
OECD Secretariat provides TGs and other documents on the OECD website for public commenting, collects comments and provides further support to lead Member country
Forward approval by WNT to CBC for formal declassification
OECD Secretariat publishes TGs and other documents on the OECD website.
OECD Secretariat coordinates the development of harmonised templates for information reporting
A team in the OECD Secretariat (8 staff members for the test guidelines programme) provides support for the OECD Test Guidelines Programme.
Continuation of engagement and funding is in the power of Member Countries.
OECD Working Parties can have preliminary discussions on project proposals with leading Member countries and/or leading institutions
Delegates of WPMN and other OECD bodies support National Coordinators to nominate experts for (Ad Hoc) Expert Groups
When experts in the topic, delegates from national delegations can provide expert advice themself.
If not experts, Delegates of WPMN and other OECD bodies support their National Co-ordinators and leading institutions to gather the data and coordinate the advancements of the work (e.g. collect feedback from a national network of experts)
OECD working parties provide comments on the draft document(s)
Apart from the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT), several other working parties under the Chemicals and Biotechnology Committee perform and discuss different parts of the work in detail, e.g. on Good Laboratory Practice, Biocides, Pesticides, Safety of Novel Foods and Feeds, Hazard Assessment, Exposure Assessment, Risk Management, etc.
The Working Party on Manufactured Nanomaterials (WPMN) is worth specifically mentioning here. As nanomaterials started to be used in commercial applications, OECD launched a programme of work in 2006 to ensure that the approaches for hazard, exposure and risk assessment for manufactured nanomaterials are of high quality, science-based and internationally harmonised in line with the chemicals programme and its Mutual Acceptance of Data (MAD) agreement. WPMN gathers delegations from Member countries, OECD key partners, the European Commission, industry, non-governmental organisations and standard organisations interested in the field of manufactured nanomaterials and, more recently, advanced materials. From its members, the WPMN elects a bureau and a chairperson. The work is coordinated and supported by the OECD secretariat. For more in-depth work the WPMN forms subgroups dedicated to different topics. In its subgroups and in the plenum new proposals to draw/revise a TG/GD are discussed. In close collaboration with WNT (members of), the WPMN continue to develop/revise TGs/GDs where necessary.
WPMN works closely with WNT in discussions on the needs for TGs/GDs for nanomaterials and may nominate experts for (Ad Hoc) Expert Groups when nanomaterial expertise is required. Joint WPMN-WNT Expert Groups have been established to facilitate discussions on WNT overarching topics for nanomaterials (See From science to standards and harmonised OECD Test Guidelines - NanoHarmony training).
Continuation of engagement and funding is in the power of OECD Member countries. It is also up to the Member countries to set the criteria for the selection of members of their national delegation and the responsible institutions. Similarly to the designation of the National Coordinator, every Member country does it in different ways, depending on how big the country is and/or how many experts are available. For example, sometimes only one delegate represents its country at various OECD committees and working groups/parties.
Business & Industry Advisory Committee (BIAC) can inform its network of project proposals at an early development stage
BIAC can nominate experts for (Joint) Expert Groups
BIAC can contribute to the development of the OECD TG/GD (potentially including further research, an ILC and validation report, and drafting and commenting on the document versions)
BIAC can provide comments on OECD draft document(s)
BIAC can collect feedback from national organisations on the need to update or develop TGs/GDs
Business & Industry Advisory Committee (BIAC) is the officially recognised institutional business stakeholder at the OECD. They connect the private sector business community with the OECD and its governments. In different OECD working parties, they provide the business perspective in the discussions. Representatives are generally recruited from affiliated companies and national associations (For current members | Business at OECD (BIAC)).
Continuation of engagement and funding is in the power of industry.
International Council on Animal Protection (ICAPO) can inform its network of project proposals at an early development stage
ICAPO can nominate experts to take part in OECD activities on ICAPO's behalf, both for OECD bodies and for (Joint) expert Groups
ICAPO may contribute to the development of the OECD TG/GD (potentially including further research, an ILC and validation report, and drafting and commenting on the document versions)
ICAPO can provide comments on the draft document(s)
ICAPO works to ensure that Member countries abide by their OECD treaty obligations under the Mutual Acceptance of Data.
International Council on Animal Protection (ICAPO) ensures the widest possible integration of alternative methods in the OECD’s influential guidelines and programmes. ICAPO works to fully incorporate alternative methods that can replace, reduce, and refine animal use (the "3Rs") in OECD activities, in the interest of animal protection, public health and sound science. ICAPO brings the views of more than 30 million members and supporters throughout Asia, Europe, and North America to the table. ICAPO has a wide membership from 10 national and international organisations.
With regard to TGs, representative bodies act on behalf of their members and will often provide advice to OECD and other standardisation bodies, as well as direct to government policymakers and regulators. ICAPO carries out its work at the OECD by participating in relevant OECD meetings and OECD bodies, commenting on OECD draft TGs and other documents, and nominating outside experts to take part in OECD activities on ICAPO's behalf. ICAPO also works to ensure that Member countries abide by their OECD treaty obligations under the Mutual Acceptance of Data provision, which obligates Member countries to accept data from OECD-approved TGs instead of requiring duplicative animal testing. ICAPO brings its technical and policy expertise to various OECD activities including the steering group on testing assessment at the Working Party on Manufactured Nanomaterials (WPMN), where they are also able to raise and respond to agenda items.
ICAPO’s funding is generated through membership and donations (private funding).